VAC Dressings for Colorectal Resections

Surgical Site Infection Clinical Trial

— VACCRR  

Official title:

Incisional Negative Pressure Wound Therapy Following Colorectal Resection: a Single Site, Prospective, Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02967627
• Other study ID #: H16-02565
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2016
• Last updated: November 17, 2016
• Start date: November 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2016
• Source: University of British Columbia
• Contact: Mitchell A. Webb, MD
• Phone: 778 242 9807
• Email: mitchell.webb[@]alumni.ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Surgical Site Infections (SSIs) and wound complications are common occurrences following colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has developing evidence for improving wound complication rates in certain populations. However, there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We propose a study in which patients are randomized into one of two treatment arms: 1) incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30 days for diagnosis of infection or wound complication. We will compare primary outcomes in each group using Chi-Squared statistical testing in order to report a Absolute Risk Reduction and Number Needed to Treat

Description:

Purpose: To evaluate if incisional Negative Pressure Wound Therapy (iNPWT) confers a lower rate of Surgical Site Infection (SSI) or wound complication compared to standard treatment of elective colorectal resection laparotomies.

Justification: Colorectal resection with bowel anastomosis is a clean-contaminated procedure known to have increased rates wound complication. Techniques like the use of incisional wound barriers, antimicrobial eluding dressings or iodine washout have been assessed in an attempt to reduce occurrence. However, evidence for their efficacy is not compelling for surgeons to universally adapt. Meanwhile, negative pressure wound therapy has demonstrated impressive efficacy in the management of complex and non-healing wounds. And recently, NPWT has become an area of interest in managing, not only open wounds, but closed wounds as well. The benefit of this therapy is yet to be clearly defined in the elective colorectal resection patient population, however.

Null hypothesis: There is no difference in SSI or wound complication rate in standard and iNPWT groups.

Design: Single-institution, prospective, randomized, open-label, superiority trial

Statistical Analysis: Assuming a complication rate of 20-30% and a relative risk reduction of 50%, we will recruit 400 patients (200 in each group) to achieve a power of 80% and type 1 error of 0.05. Primary endpoints will be: Wound Complication - defined as presence of seroma, hematoma, dehiscence, SSI - and SSI reported independently. Secondary endpoints will include: Length of Stay, ER visits related to SSI, Complications (according to Clavien-Dindo classification), need for and duration of home care related to wound care, and wound VAC specific complications (local reaction to adhesive dressing, blisters, failure of vacuum, need for early removal). Primary endpoints will be assessed according to intention-to-treat principle using Pearson's chi-squared test. In the event that baseline characteristics are significantly different, a secondary analysis using multivariable logistic regression will adjust for the effect of the difference. A p value of < 0.05 will be used to determine significance. Results will be presented as an absolute risk reduction as well as number needed to treat to prevent one wound complication. Secondary outcomes will be compared using a Mann-Whitney U-test for non-normally distributed continuous variables and chi-squared for categorical data.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• elective colorectal resection for benign or malignant disease

• surgery involves an anastomosis

• open or minimally invasive technique

• midline laparotomy used for specimen extraction

Exclusion Criteria:

• under 19

• allergy/sensitivity to adhesives

• immunocompromised

• pregnant

• emergency surgery

• elective surgery

• additional procedures performed at time of surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematoma
• Seroma
• Surgical Site Infection
• Surgical Wound Infection
• Wound Complication
• Wound Dehiscence
• Wounds and Injuries

Intervention

Device:
• Incisional Negative Pressure Wound Therapy (iNPWT)
Incisional Negative Pressure Wound Therapy devices are lightweight, self contained, portable battery powered (or line powered), suction pumps for medical procedures where secretions and other body fluids and infectious materials must be removed through the application of continuous or intermittent negative pressure. The pumps are operated through computer software, having help and alarm features. The device is indicted for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The pumps may be used at patient's bedside. These are suitable for use in either hospitals or long term care facilities and nursing homes. These devices will be applied to closed laparotomy incisions with the aim to provide three days of continuous negative pressure of - 100mmHg.
• Sterile Gauze Dressing
In most cases, self-adhesive, absorbent dressings will be used for standard wound therapy. However, surgical teams may decide on alternative forms of sterile gauze dressings, as long as the wound site is kept clean and dry. Dressings should be taken down on the second post-operative day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superficial Surgical Site Infection (SSI)	Infection occurring within the first thirty days after surgery with at least one of the following: 1) purulent drainage from the superficial incision; 2) organisms obtained from an aseptically obtained culture of tissue or fluid from the superficial incision; 3) at least one of the local signs of infection; 4) superficial incision deliberately opened by the surgeon (unless the culture is negative)	30 days post op	No
Primary	Wound Complication	At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption	30 days post op	No
Secondary	Length of stay	Number of days spent in hospital post op	approximately 5-10 days on average	No
Secondary	Wound-related visits post surgery	Number of wound-related visits to primary care physician, nurse practitioner, or emergency for concerns related to laparotomy incision.	30 days post op	No
Secondary	Need for and duration of home care	Did the patient require home care nursing for wound care? If so, how many visits?	30 days post op	No
Secondary	Blistering/reaction to wound dressings	Did the patient develop skin blisters or hypersensitivity reaction secondary to their wound dressings?	3 days post op	No
Secondary	Post Op Complications	Did the patient develop any major complications - as according to Clavien-Dindo classification?	30 days post op	No